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Purple Book reference family · 351(a) biologic

Antihemophilic Factor (Human) (Hemofil M)

Antihemophilic Factor (Human) is an FDA-licensed reference biologic from Takeda Pharmaceuticals U.S.A., Inc..

351(a) biologicBLA 101448 Takeda Pharmaceuticals U.S.A., Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2001

Reference product

Originator biologic
351(a)BLA 101448

Hemofil M Antihemophilic Factor (Human)

Takeda Pharmaceuticals U.S.A., Inc.

View full reference-product record
Approved
Marketing
Rx
Center
CBER
Patents
None listed

Molecular structure

RCSB Protein Data Bank

Experimental 3D structure for Antihemophilic Factor (Human) from the RCSB Protein Data Bank (PDB 3CDZ).

3D molecular structure of Antihemophilic Factor (Human) (PDB entry 3CDZ)

Interactive biological assembly from PDB entry 3CDZ. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference Antihemophilic Factor (Human) product.

    25 yr 11 mo ago

Antihemophilic Factor (Human): frequently asked questions

Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.

Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for Antihemophilic Factor (Human).

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